Data / Medical devices / United States / Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics, Inc.: FDA-registered device maker in Malvern, PA, United States, 2 510(k) clearances

Name: Fujirebio Diagnostics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fujirebio Diagnostics, Inc. is registered with the FDA (registration 2521625) in Malvern, PA, United States. It lists 20 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 16, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2521625
Address: 201 Great Valley Parkway, Malvern, PA, United States, 19355
Owner or operator: Fujirebio Diagnostics, Inc. (10022860)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export
First device listed: October 17, 2007
Registered through: 2026
Brand names listed: ADVIA Centaur XPT Cytokeratin Fragment 21-1 MCM (CYFRA MCM) - Siemens, ADVIA Centaur XPT Tumor Marker Quality Controls (TMQC) - Siemens, ARCHITECT BNP Calibrators (China), ARCHITECT BNP Reagents (China), ARCHITECT BNP Reagents, Calibrators and Controls, ARCHITECT BNP-JP Calibrators, ARCHITECT BNP-JP Controls, ARCHITECT BNP-JP Reagents and more

Devices it lists

Device	Product code	Class	Role	Source
AlzheimerS Disease Pathology Assessment Test	QSE	2	Manufacturer	accessdata.fda.gov
Calibrator, Secondary	JIT	2	Contract manufacturer	accessdata.fda.gov
Calibrators, Drug Specific	DLJ	2	Contract manufacturer	accessdata.fda.gov
Cyclosporine	MKW	2	Contract manufacturer	accessdata.fda.gov
Cytokeratin Fragments 21-1 Eia Kit	OVK	2	Manufacturer for export	accessdata.fda.gov
Enzyme Immunoassay, Methotrexate	LAO	U	Manufacturer for export	accessdata.fda.gov
Enzyme Immunoassay, Tracrolimus	MLM	2	Contract manufacturer	accessdata.fda.gov
Galectin-3 In Vitro Diagnostic Assay	OSX	2	Contract manufacturer	accessdata.fda.gov
Immunoassay Blood Test For Amyloid Pathology Assessment	SET	2	Manufacturer	accessdata.fda.gov
Ovarian Adnexal Mass Assessment Score Test System	ONX	2	Contract manufacturer	accessdata.fda.gov
Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	LTJ	2	Contract manufacturer	accessdata.fda.gov
Reagent, Coronavirus Serological	QKO	N	Contract manufacturer	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sirolimus Test System	NRP	2	Contract manufacturer	accessdata.fda.gov
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	NIG	2	Contract manufacturer	accessdata.fda.gov
System, Test, Immunological, Antigen, Tumor	MOI	2	Contract manufacturer	accessdata.fda.gov
System, Test, Thyroglobulin	MSW	2	Manufacturer for export	accessdata.fda.gov
Test, Epithelial Ovarian Tumor Associated Antigen (He4)	OIU	2	Contract manufacturer	accessdata.fda.gov
Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	LTK	2	Contract manufacturer	accessdata.fda.gov
Test, Natriuretic Peptide	NBC	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 16, 2025	K242706	Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio	SET	Substantially Equivalent	Fujirebio Diagnostics,Inc.	accessdata.fda.gov
May 4, 2022	DEN200072	Lumipulse G ß-Amyloid Ratio (1-42/1-40)	QSE	Unknown	Fujirebio Diagnostics,Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
December 11, 2025	98232	Class II	Ongoing	Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/-Amyloid 1-42 Plasma Ratio is an in vitro diagnostic (I	Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as hav	accessdata.fda.gov
July 29, 2010	56427	Not yet classified	Terminated	MESOMARK Humanitarian Device. Authorized by Federal Law for use as an aid in monitoring of patients diagnosed with mesothelioma. Each kit contains 96 tests. MESOMARK is an enzyme linked immunosorbent assay (ELISA) for th	presence of material attached to the bottom of some wells in places visible to the naked eye, which caused an overestimation of the sample.	accessdata.fda.gov

Compare with other makers

Updated February 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.